As well as the necessary use and maintenance documentation, which is delivered as an integral part of every machine, at the customer's request the Marchesini Group supplies a Validation Protocol, drawn up in accordance with cGMP andd GAMP 4 standards, created and used for pharmaceutical sector.
It has a team of experts working exclusively on this sector, perfecting system Functional and Design Specifications, and all of the test sheet necessary for the testing which will be carried out on the system during FAT and SAT stages.
Document such as QP, FS, HDS, SDS, IQ/OQ Test Protocol and others are carefully drawn up, in constant partnership with the customer.
